1. Field of the Invention
The present invention relates, generally, to the field of collection, storage, transfer and display of health data, and more specifically, to the field of collection, storage, transfer and display of health data on portable devices.
2. The Problems
Immediate availability of accurate, reliable past medical history of a patient is important in most health care encounters. Caregivers need data from the past health history of a patient, in order to arrive at the correct diagnosis, institute the appropriate therapy and ensure the continuity of care. In emergency medical situations, incomplete information can lead to disastrous clinical results. Even in routine encounters immediate availability of up-to-date, accurate, and comprehensive health data at the point of care is often extremely important. A physician spends in an average clinic visit about 30% of his time on data collection. Usually, clinicians try to get the relevant data from the past health history of a person, mainly from one or more of the following sources: the patient himself, conventional paper based medical records, a variety of documents (letters, discharge summaries, X-rays, ECGs, laboratory reports, consultants' reports, etc.), computer-stored medical records (on personal computers, traditional mainframe computers, computer based medical record systems, and web-based medical records) and directly from other health care providers. Unfortunately, in most cases there are problems, that prevent clinicians to get all the relevant data from the past health history of patients, at the point of care.
The main problem is that, the personal health records of a person are usually distributed amongst multiple health care providers. A patient may obtain the services of a number of providers when being treated for a single particular illness or injury. Over the course of a lifetime, a patient may receive the services of a large number of providers. Therefore, parts of the health data of one patient may be stored in paper based and/or computer based medical records of his primary care physician, one or more consultants, inpatient departments and outpatient clinics of hospitals, emergency departments, sports medicine clinics, public health clinics, dentists' and optometrists' charts, nursing homes and other institutions such as the armed forces, occupational health programs of employers, schools, colleges, universities etc. In addition, modern transportation for business or travel increases the possibility, that medical service or continuation of care will be needed and documented in medical records in one or more locations anywhere in the world. Therefore, linking, integrating and presenting all the data from the past medical history of a patient, that are stored on multiple paper based records and multiple computer based records, so that the caregiver at the point of care, will have an integrated view of all the data is usually impossible. At best, each one of these sources may be able to supply, only the part of the health information that is recorded and stored in its archives. Unfortunately, even the limited data that caregivers can get from each one of these sources are often incomplete and inaccurate.
Another universal problem that prevents clinicians to get all the relevant data from the past medical history of patients, at the point of care from all health records of a patient, is the fact that very often, one person has different names and/or identification numbers in different paper based and/or computer based medical records. Many countries do not have unique patient identifier systems. Therefore, in these countries, when a person is admitted to a hospital, he receives a patient ID that is used only within that hospital. If a patient is admitted to several hospitals, he will have several patient IDs. In the United States a Social Security Number is not always assigned at the time of birth and therefore, important data collected on newborn babies, are often stored in records that have different ID numbers than the permanent Social Security Numbers. When an unconscious person is admitted to an emergency department without his Social Security Number, data related to that event are recorded and stored in a medical record that is assigned a temporary Social Security Number, that is obviously different from his permanent Social Security Number. If the temporary and permanent Social Security Numbers are not merged in a timely fashion, it becomes very difficult or impossible to access, link and integrate the important health data that are stored on temporary medical records, with data that are documented and stored on permanent records. Also, the same patient may be registered under different names and ID numbers because of typing errors, marriage, divorce or use of pseudonyms. There are many documented cases in which one person has more than one permanent social security number (there are about 280 million Americans and about 360 million active social security numbers). There are also identified cases in which two people have the same Social Security Number. Thus, many people have more than one identifier. Master Patient Indexes cannot solve this problem. They are useful as internal aggregators in health institutions, but not as a way to identify and get access to patient records externally. Therefore, at least part of the personal health data, that are recorded in some of the health records of a person cannot be linked, integrated and used, when these data are needed at the point of care.
Usually, the patients themselves cannot supply all the data that caregivers need at the point of care. Some patients simply do not know the details of their past medical history, because their physicians do not tell them important facts. Other, patients cannot supply the information, because they did not understand what was explained to them. Many caregivers prevent patients to view their own personal records, and patients rarely receive detailed information in written form about their treatment in hospital or specialist clinic. Thus, they must rely on their own understanding of what has happened to them. Therefore, often a significant disparity occurs between perceptions of physicians and patients regarding hospital discharge instructions (Calkins, 1997). In a study done at the Mayo Clinic, patients and physicians were asked to report on major health problems and other problems dealt with during an ambulatory-care encounter. Patients failed to report 68 percent of problems that their physicians listed as being addressed during a specific encounter (Scheitel, 1996). In addition, 54 percent of the “most important health problems” that physicians discussed during the encounter were not even listed among those, that patients recounted after the encounter. In emergency situations, the patient may be unconscious and not be able to provide information. Even if conscious, a patient may be incapable of providing complete, accurate, exact and comprehensive information, when he is tired or painful and can not concentrate. There are many cases in which patients supply unintentionally misleading information. For instance, nine out of ten patients who honestly believe they are seriously allergic to penicillin are mistaken (Saxon, 1987).
The memory of patients is not always reliable. A number of physiological and pathological conditions may be responsible for temporary or permanent loss of memory. Studies have shown, that a patient's ability to recall information presented by physicians in outpatient clinics, ranges from 50 percent at 5 minutes to 56 percent at 1-2 weeks. When patients are exited, tense or frightened in the examining room, they tend to forget to tell the physician the most important facts about their medical problems. In a study of patients' recall of medication information, 60 percent of patients did not know the names of their drugs and 20 percent did not know the purpose of their medications (Ley, 1982). In elderly patients distinct memory impairment is common (Welsh-Bohmer, 1999). Even young and healthy persons may be incapable of providing complete, accurate, exact and comprehensive information related to their past medical history. The recall of injury events, which resulted in seeking treatment from a doctor, nurse or dentist, or going to the hospital for treatment in the previous two years, was studied for a group of 631 thirteen year olds (Langley, 1989). This study showed that 39% of all visits to the accident and emergency department were not recalled. A poisoning study showed that one fifth of the entire previous year's poisoning experience was reported for a one-month period immediately preceding the interview (Wherle, 1960). There are many other studies that document human memory failures (Sharp, 1990). Thus it is clear that the data that patients can supply to caregivers about their past medical history at the point of care, are very often incomplete, inaccurate, or even false and misleading, and can lead to serious errors in diagnosis and therapy.
The paper based medical record, is often not one entity, even within one institution, because data related to accident and emergency visits are very often stored separately, and many other departments and services maintain separate and/or more detailed patient data files that are not part of the central record. Some studies indicate that when scheduled and unscheduled appointments are considered together, the entire medical record is not available 30%-40% of the time. The high rate of unavailability of paper based medical records is attributed mainly to the following causes: patients being seen in two or more clinics on the same day, charts not being forwarded, physicians keeping records in their offices or removing them from their offices, and records being misfiled in the file room. Another reason for unavailability of paper based medical records is, that paper based medical records are usually stored for up to 25 years, depending on state laws. Then, because of limited storage space in their archives, some institutions destroy the old records, X-ray films and other documents, ignoring the fact that the data may be needed many years later for care of elderly patients.
Even in cases, in which a paper based medical record is available at the point of care, extraction of data form the record is usually difficult. The contents of a conventional paper based medical record is often a mixture of admission notes, follow-up reports, laboratory test results, ECG strips, administrative documents, consultants' notes and recommendations, therapy plans, medication records, informed consent forms, flow charts etc. Much of the information in the record is obsolete, redundant and duplicated. Significant parts of the data are handwritten and often illegible. In one study, the main finding was that 50 percent of handwritten emergency department charts could not be properly evaluated due to poor handwriting. Notes pertaining to a single problem may be pages apart, depending on the time intervals between visits. Therefore, dozens of pages must be thumbed through in a paper-based record, in order to find the desired information (Brancati, 1992; Brown, 1988). A study that was conducted in a university hospital clinic, to determine the success with which physicians find patient information using traditional hospital paper based medical records as a source of data, showed that even though the medical records were present 95% of the time in their study, physicians could not find all the information they were looking for, in up to 81% of the visits (Tang, 1994). Therefore, it is not surprising that house officers frequently do not try to obtain previous paper based medical records (Fred, 1994).
Even in cases, in which a paper based medical record is available at the point of care and is easily legible, extraction of data form the record is usually difficult. Notes may be too ambiguous to allow proper interpretation, because data are recorded in narrative style that contains complex expressions. In these narrative expressions that are recorded in natural language, often (24%) two or more data elements are linked together. It is also common (39%) that in natural language one data element may be embedded in another. Studies have shown that these expressions increase the cognitive load and the reader may need more time and effort to extract from these expressions the data elements (Patel, 2000). In a sentence in which each word can have different meanings, the whole sentence may have more than 10 interpretations (van Bemmel, 1997). In the time constraints of most points of care, this may lead to serious errors in interpretation of the meaning of complex notes, which in turn, may lead to errors in medical decisions and actions. Even when each sentence or paragraph is accurately understood, the scattered notes make it difficult to obtain an overview of the complete medical history of a patient, especially in cases of patients that are treated for more than one complaint or disease.
Although paper based medical records are technically transferable, it is a generally accepted principle that the patient record is maintained and owned by the health care institution or practitioner providing care. This principle, which is established by statutes and regulations in many states, grants the provider control over the physical document (CPRI, 1994). Therefore, the paper based medical records of a patient that is treated in one institution, are usually not transferred for use by medical personnel in another institution, especially when the patient needs medical care in another city, country or continent. Theoretically, copies of medical documents carried by the patient, could supply at the point of care, all the data from the past medical history of a patient. Already in 1973 it was suggested, “that legislation be passed to require that a complete and unexpurgated copy of all the medical records, both inpatient and outpatient, be issued routinely and automatically to patients as soon as the services provided are recorded” (Shenkin, 1973). This suggestion is not practical, because it is very difficult to carry paper copies of complete medical records and also, because the fact that there are caregivers that prevent patients to view and copy their own personal records. Thus, most patients do not carry with them at all times, paper copies of all their medical records, discharge summaries, roentgenograms, electrocardiograms, letters, reports of laboratory tests and procedures.
Timely access to patient data that are stored on computers is very often prevented from caregivers that need fast access to the data at the point of care, mainly by one or more of the following reasons: absence of the necessary hardware or software at the point of care, lack of interoperability of hardware or software between multiple vendor systems from various sources that use different formats and standards (which also change over time), lack of access to a reliable communication network, data protection policies and lack of adequate skills required to use the system. Thus, for instance, a physician that is called to examine and treat a person in an emergency situation in the middle of the street, a paramedic in the field or a nurse visiting an elderly patient at his home, may not have immediate access to the relevant data, because of lack of access to the necessary hardware, even if they are authorized to access the data of the relevant remote computer.
Many caregivers cannot use computer based medical record systems efficiently, mainly because these systems are often difficult to learn and difficult to use (Sittig, 1999). A typical screen in most electronic medical record systems contains dozens of icons and pull down menus, which the user is supposed to know well, in order to use them for many tasks, such as entry and retrieval of administrative, clinical, scientific, financial and statistical data, and also scheduling, typing letters, prescriptions and reports, sending and receiving e-mails, etc. Although vendors describe these programs as user-friendly, they are usually complex. Many studies have shown that computer based interactions take longer than paper based interactions (Krall, 1995) and that users sometimes avoid documentation of details, if they feel that it will take too much of their time and effort.
In most electronic medical records data are clustered in groups that are not oriented to clinical scenarios. In order to enter or retrieve data that they need, related to one problem, clinicians, need usually to use many screens. They have to know which one of the many screens show laboratory test results and which show reports of X-ray examination, which screens show diagnoses and which show treatments or procedures, etc. In order to get all the data that they need to review and deal with one problem, they must usually “jump” from one screen to another. Thus, most computer based medical records do not enable every user, at the point of care, to see in one view all the data that he needs, before he makes a decision. This may lead to delays and errors in medical decisions and actions.
Even in cases, in which those barriers do not exist, it may be difficult to get accurate data, mainly because of the methods of data entry in computer based health records. In most of them data are recorded and stored by selecting terms from one or more lists of a variety of classifications, lexicons, data dictionaries, nomenclatures, and structured coded controlled vocabularies that are presented on the screen. Using coded data entry does not allow caregivers to express the complaints of their patients in the patients' own words. Using controlled terminologies from a list to enter data, do not allow caregivers to record exactly what they themselves want to express in their natural professional language. Also, very often clinicians cannot record important observations using coded data entry, because there are no codes to do it (Chute, 1998). Thus, data that are recorded using classifications, nomenclatures, and structured coded controlled vocabularies, are often not accurate and incomplete. Data entry by selecting an option from a list may also increase the risk of entering errors that are difficult or almost impossible to detect. For instance, it is very easy to click option 1 in a list (that stands for “yes”) instead of option 2 (that stands for “no”) or to click option 3 in a menu (that stands for “electrophoresis”) instead of option 4 (that stands for “electrolytes”), which may have serious consequences when these erroneous data are used by clinicians, at the point of care, to make a diagnoses or decide on diagnostic procedures or treatments.
Use of predefined date-fields to record time in computer based systems, may result in confusion. For example, a calendar date is expressed in the United States in the MM/DD/YY format. In Europe the DD/MM/YY format is used. In other countries the YY/MM/DD, the DD/MM/YYYY or a variety of other formats are used to represent dates. Thus, 07/01/21 may mean “Jul. 1, 1921 ”, “Jan. 7, 1921 ” and even “Jan. 21, 1907 ”, depending on the country and the format used. Use of predefined date-fields, does not allow accurate documentation of temporal uncertainty and multiple temporal granularities, and may result in entering inaccurate or even false information. For instance, when a patient does not know or does not remember the exact day and month of an event, clinicians try to document the event using the MM/DD/YY as 00/00/YY, or even better as ??/??/YY. Unfortunately, very often the software does not allow to enter such “invalid” dates, ignoring the fact that in collecting data, we are often faced with answers from a patient, expressed in natural language, which cannot fit into any predefined date field. Therefore, the users are driven to enter a false day and month, to satisfy the system. Entering such inaccurate or false data may confuse a physician about the time sequence of events, from the past medical history of a patient, and may have serious consequences, when these data are used by clinicians, to make diagnoses or decide on diagnostic procedures or treatments.
The protection of privacy, confidentiality and access control to patient information in paper based and computer based medical records are often inadequate. Usually, a patient cannot maintain anonymity. In most cases, at the time of registration, a patient must provide personal identifying information such as name, date of birth, address, telephone number, marital status, occupation, ID number etc. Very often, patients have limited control or no control on the security, confidentiality and access to these personal health data, which are stored in patient records. Authorized users of health records, mainly those that have “role based access” to patient specific information, and who are not directly involved in patient care, may abuse their privileges by accessing information for inappropriate reasons or uses, whether to view records of friends, neighbors, or coworkers. There is also a pervasive use of compiled health information for marketing purposes, which constitutes a serious invasion of a person's privacy, and against which it is very difficult to fight. Many cases are reported in the media. These universal problems, of misuse and unauthorized disclosure of personal health data, that many people consider to be one of their most important secrets, has caused patients to withhold from recording in medical records clinically important, but sensitive personal information, because they think that if the information will be known, it might threaten their employment, insurability or credit rating. Also, parents, under some conditions, may withhold information about a child from medical professionals for the same reasons (MacFarlane, 1992). Furthermore, physicians are being forced to censor essential chart information that might harm the patient. For example, a physician may hesitate to record that a prominent executive has become a sloppy dresser, although this might be a valuable clue to incipient dementia.
The security of patient information in paper based and in computer based medical records can be protected by a combination of policies, procedures, and a variety of technological measures. Implementation of the necessary measures is often complex and expensive. Therefore only a limited number of health care institutions are able to install all the necessary components and use them adequately. Protecting the privacy and security of sensitive patient information on remote computers requires that the digital identity of the patient, physician and clinic or hospital be authenticated before the patient's clinical information is released to the patient-approved physician. In institutions that install such methods and procedures, the protective measures themselves are often significant barriers to the timely access to patient data at the point of care (Overhage, 2002). This situation is very common. Caregivers that are not affiliated with a specific institute (that work in another institute, another city, country or continent) are usually not authorized in advance to access the data that are recorded and stored in computer systems of that institute, and therefore can not use patient specific data that are stored in that institute, when they need the data at the point of care.
Another serious problem with computer based medical record systems is that they have many secondary uses, ranging from billing and statistics to clinical research and national health policy development. The imposition of cost control and reimbursement regulations, often force users to enter inaccurate, incomplete and even false clinical information into the personal medical records of their patients, because they require the information to be framed in arbitrarily unrealistic terms and classes. For instance, when a physician believes that a given patient should be hospitalized, and the admission criteria require a respiratory rate of 34 per minute and the treatment standards call for cardiac rhythm electronic monitoring and intravenous therapy, he may be tempted to enter false data, to satisfy the admission criteria (Burnum, 1989). After such inaccurate, incomplete or false data are recorded in medical records, and due to hiding of important data, it may be difficult or even impossible to detect that the data are unreliable. Obviously, using inaccurate, incomplete or false data at the point of care, may lead to serious errors in diagnosis and therapy.
Clinical reporting represents a major cost to the health care industry, in terms of both dollars and time. Writing detailed discharge summaries, referral letters and consultation reports by hand onto paper has two significant disadvantages: it is time consuming and may be illegible. Dictating, printing, reviewing, and approving printed medical documents are time-consuming processes. The transcription services used by many physicians as a mechanism for generating clinical documentation are also expensive and error-prone. While they fulfill the traditional purpose of documenting patient encounters, it is difficult or impossible to integrate them with other records of the (increasingly electronic) longitudinal patient record. In most cases, these documents contain only part of the data that caregivers need at the point of care.
Sending information such as referral letters, discharge summaries, and copies of documents to the point of care by regular mail is often very slow (Tulloch, 1975; Bado, 1984; Penney, 1988). A study that looked at all hospital discharge communications concerned with acute admissions from one general practice, found that over half the patients contacted their general practitioners after discharge, before the general practitioner had received information about the hospitalization. The general practitioner received no information for 11% of the discharged patients (Mageean, 1986). Therefore, primary care physicians are frequently unaware of the discharge plans for their hospitalized patients. Specifically, because discharge summaries are not readily accessible, the primary care physician responsible for the post-discharge care of a patient has no quick and reliable access to information about a recent hospitalization. Information such as the reason for the hospitalization, test results, diagnosis, and discharge medications may have a profound impact on how the patient is managed in clinic post-discharge. Additionally, the inpatient physician has no reliable way of communicating requests, such as further testing needed, to the outpatient physician (Moore, 1997).
Transmitting documents to the point of care by standard fax machines is not secure. Faxes may be easily sent to the wrong place by an error in dialing (Genesen, 1994). Faxes may also be misdirected by pressing the wrong speed-dial button, and thus enable inadvertent disclosure of sensitive personal medical data of a person to his employers, coworkers and others, whose fax numbers are used often by the sender. These common problems with faxing may prevent timely arrival of important personal data of a person that are sent to the point of care. Interception and unauthorized capture of faxes during transmission on phone lines is extremely easy, and neither the senders nor the receivers, know when this happens. Faxes that are printed on thermal paper may fade and become illegible after a relatively short period. Because of these problems, it is not recommended to transmit personal health information, on standard fax machines. Secure fax devices can authenticate the sender and receiver, encrypt the faxes before transmission, and store faxes in electronic mailboxes that can be opened by the user only by entering a user ID and PIN to get the faxes out. Unfortunately, these systems are expensive and enable to transmit faxes securely only within a closed network of fax machines, in which secure fax devices are installed. Therefore only a limited number of health care institutions are able to install and use them.
Internet access to patients' records, using PC based browsers, is not possible in many situations, mainly because of the absence of the necessary hardware or software at the point of care, lack of access to a reliable communication network and lack of adequate skills required to use the system. In addition, in order to be able to access the data, the person requesting the information must know his patient's web address (URL), and the system must confirm the requestor's “need to know” and the identify the patient (Schoenberg, 2000). If the requester does not know the URL and cannot supply the relevant identifying data, he cannot gain access to the needed health data. Also, caregivers that need immediate access to important data at the point of care cannot rely on web-based transmission of patient specific data, because Internet paths consistently show large time-of-day and day-of-week variability. The effective transmission capacities of network pathways are generally reduced during the business day. This appears to be directly related to the much higher level of use during the day. The transmission capacities are the greatest during the night or early morning hours. Typically, for web sites tested in the United States and other G7 countries, the effective transmission capacities are reduced on the order of 40 to 95 percent during local business hours compared with weekend and other off-peak hours. The data suggest that even high-bandwidth (e.g., 10 to 45 Mbps) Internet pathways may suffer from significant capacity reductions because of traffic congestion during peak hours, probably reflecting a loaded Internet infrastructure in some geographic regions (Wood, 1998).
E-mail messages are inherently insecure, and may suffer during transmission from unauthorized or accidental modification, destruction and disclosure. Unencrypted, unauthenticated e-mail messages may be corrupted or incomplete, or may incorrectly identify the sender. Currently, standard e-mail systems do not use encryption and strong authentication methods. Many standard e-mail systems use store-and-forward protocols, that leave copies of messages on various insecure servers and end-user hard drives. E-mail messages may be misdirected by mistakes such as clicking the e-mail address of another person or by selecting the “reply all” option, which sends e-mails to the sender's and also to one or more other e-mail addresses. These problems may enable inadvertent disclosure of sensitive personal medical data of a person to his employers, coworkers and others, whose e-mail addresses are used often by the sender. Patients or physicians who use e-mail for medical data interchange in the workplace are not assured confidentiality and may unintentionally expose sensitive details of illness or social circumstances to an employer because, legally e-mail systems allow the employer access to all messages generated and read by employees. Further, patients using family e-mail accounts at home may lack privacy from spouses, children, or parents.
Receiving the relevant past medical history of a patient by direct telephone communication from the point of care, with other clinicians, is often impossible. Most caregivers at the point of care do not have the time to find telephone numbers of the relevant clinicians and to contact them. The phone call interrupts workflow and requires the receiver to be available. Health information that caregivers receive by phone calls from patients is often not entered into the medical record and is therefore not available at the point of care. Also, information that is communicated by unprotected telephones, may be heard by unauthorized people, on parallel connected lines and neither the senders nor the receivers, know when this happens. But, even if a caregiver at the point of care succeeds to contact another caregiver by protected telephone line and gets data from the past medical history of a patient, it might be extremely dangerous to rely on these data. Communication failures are a large contributor to adverse clinical events and outcomes (Coiera, 2000). In a retrospective review of 14,000 in-hospital deaths, communication errors were found to be the lead cause, twice as frequent as errors due to inadequate clinical skill (Wilson, 1995). Furthermore, about 50 percent of all adverse events detected in a study of primary care physicians were associated with communication difficulties (Bhasale, 1998).
Consumer health records are usually created and maintained by individual patients on the web. The documentation is based upon the patient's own understanding of his health conditions, medications, problems, allergies, vaccination history, etc. Although consumer health records may contain important data, most caregivers do not use them at the point of care. They cannot rely on data that are entered by laypersons, for decisions on diagnoses, procedures and therapy, because these data are usually inaccurate and incomplete (Kim, 2002). In addition, the protection of the privacy, confidentiality, security and access control to web based consumer health records is often inadequate (Marshall, 1999). In PC based consumer health record systems, the software and the data are stored on the hard disk of the personal computer at the patient's home (Denton, 1999). Therefore, these data cannot be easily accessed from remote sites.
Accessing, linking and presenting patient data that are distributed across multiple hospitals and health maintenance organizations, primary care physicians and specialists' clinics, pose very complex technical and non-technical problems. These include problems of interoperability between multiple vendor systems from various sources that use different formats and standards (which also change over time), access control, routine maintenance of hardware and software, data protection laws, regulations and policies, downtime issues, training of the technical and clinical users, incompatible standards for linking and integrating patient data that are stored on multiple heterogeneous component systems and on paper based legacy systems. A variety of national and international organizations such as ISO 251, CEN 215, ASTM, HL7, CCOW, CORBA, and many others are developing standards that are supposed to enable the merger of the individual data elements stored in heterogeneous computer based systems and the provision of a patient view, rather than an organizational view of patient information. Unfortunately, the standards used in different local, regional and national organizations are often incompatible. Therefore timely access, to at least parts of the data that are stored on computer based medical records systems of large integrated health maintenance organizations, is often difficult or impossible, in many points of care.
Thus, although enormous amounts of personal health data are collected and stored for each patient in a variety of health record systems and documents, in most cases there are problems that prevent clinicians to get all the relevant data from the past health history of patients at the point of care, when the patient is seen by physicians and other health care professionals. These are very common universal problems and they have very serious consequences for patients, caregivers, insurers and society at large.
3. The Consequences
Absence of all the relevant data from the past medical history of patients at the point of care may cause critical delays in diagnosis and treatment and waste of time of the patient and caregivers. In the absence of these data, at the point of care, a patient must waste time in giving the same history time and time again, and a physician must spend during an average clinic visit 30%-40% of his time on data collection. When a physician examines a new patient that suffers from a few chronic diseases, it may take from about 15 minutes to an hour or more to collect all the relevant data from the patient and from medical records and relevant documents.
In the absence of relevant data from the past medical history of patients at the point of care, the patient must submit to the same diagnostic tests and procedures repeatedly, and insurance companies waste enormous amounts of money on unnecessary and potentially dangerous tests. In 1987 it has been estimated, that of the approximately $30 billion spent each year in the United States for medical tests, as much as 60% of that amount ($18 billion) is wasted on unnecessary tests; i.e., those which, for a given patient, would not be needed if the physician had the benefit of a reliable medical history.
In the absence of all the relevant data from the past medical history of patients at the point of care, caregivers must make decisions with minimal, inaccurate, incomplete and imprecise information or even no data. Without information, dangerous treatments may be undertaken by caregivers on a balance of risk basis, allergies and sensitivities to certain foods and drugs may not be known, and previous test results may be ignored. Lack of information about the need of a patient to receive life maintaining drugs may cause abrupt discontinuation of essential drugs such as anti coagulants, anti epileptics, anti hypertensives, anti diabetics, anti arrhythmics and corticosteroids. This may result in erroneous and harmful treatment of the person allergic to some drug, and/or in need of some drug such as insulin for the diabetic person, or digitalis for a person of heart-failure indications and the like, and even cause life threatening situations, which may necessitate repeated hospitalizations.
In the absence of up-to-date, accurate, and comprehensive relevant health data from the past medical history of a patient, at the point of care, caregivers may make fatal errors. A report from the National Academy of Sciences' Institute of Medicine, cited studies showing that between 44,000 and 98,000 people die each year in hospitals in the United States, because of mistakes by medical professionals. Even when using the lower estimate, more people die each year in the United States from medical errors than from motor vehicle accidents, breast cancer, or AIDS. Each day, more than 250 people die in the United States, because of mistakes—the equivalent of a major airplane crash each day and every day. Countless more people are injured, according to the Institute of Medicine, which ranked medical errors the eighth most common cause of death in the United States. The annual financial cost is enormous with estimates running as high as $29 billion dollars a year just for preventable medical mistakes. In fact, it is clear that the magnitude of the problem is understated in the report of the Institute of Medicine, mainly because the study concentrated only on data from hospitals and did not collect data on medical errors that occur in other places in which Americans receive health care, such as nursing homes and ambulatory care centers. Extrapolation of these American data to the 6 billion people in the world gives frightening figures.
4. Prior Art Solutions
To solve these very common and very serious universal problems that are caused by unavailability of data from the past medical history of a patient at all points of care, enormous amounts of time, money, efforts and ingenuity were invested by innumerable commercial bodies, academic institutes, national and international organizations and individuals, over decades in developing devices and methods, by which health information could accompany a patient to all health care encounters. These prior art devices include a variety of eye readable paper based data cards, patient held paper based records and booklets, lockets, pendants, necklaces, bracelets and wrist bands that carry paper based printed information, microfilm devices, bar code cards, magnetic stripe cards, health watches, integrated circuit smart cards, optical memory cards, hybrid cards, PCMCIA cards, floppy disks, portable computers, personal digital assistants (PDAs), cellular telephones, devices that carry a personal ID number and a telephone number, which emergency medical personnel can use to call an emergency response center, in order to get information about a person's health problems, medical CD cards, implantable chips, and many other devices and methods.
Each one of these prior art portable personal health information devices and methods, can at best supply only part of the personal health data of a person—but no one of the them can provide instant access to a complete, accurate and up-to-date health information of a person, whenever the information is needed, at all times, at all points of care, anywhere in the world, for all health care professionals. Also, no one of these portable personal health information devices and methods, enable to record, link, integrate, display and print in a variety of clinically relevant organized forms, all the health data of a person from birth to death, collected from all paper based medical records, computer based medical records, and all other sources of information, including personal informal paper based notes, verbal communications, phone calls and e-mails.